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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Swelling/ Edema (4577)
Event Date 03/30/2022
Event Type  Injury  
Event Description
It was reported to fresenius by a user facility clinic manager (cm) that a patient experienced an allergic reaction to the optiflux f180nre dialyzer. During followup the cm stated that the patient was approximately 1h10 minutes into treatment on a fresenius hemodialysis (hd) machine (with fresenius bloodlines) when their blood pressure increased and they experienced swelling of the face, throat constriction, and labored breathing. The cm indicated that the patient required medical intervention (specifics unknown). The patient was sent to the emergency room where they were evaluated and released. Since this event, the patient utilizes revaclear 300 dialyzers.
 
Manufacturer Narrative
A temporal relationship exists between hd therapy utilizing the fresenius optiflux 180nr dialyzer, and the serious adverse events of hypertension, facial swelling, throat constriction and labored breathing, which required an unspecified medical intervention as well as evaluation in the er. The definitive cause of the events is unknown; therefore, causality could not be firmly established. However, the patient¿s clinical manager reported the patient had a favorable response to an alternative dialyzer (baxter revaclear), which offered a substitute mode of sterilization. The cm reported the patient underwent hd without a return or worsening of the symptoms. Limited information precluded a more comprehensive investigation. Based on the totality of the information available, the fresenius optiflux 180nr dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events. While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14193528
MDR Text Key289980472
Report Number0001713747-2022-00135
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number21PU03015
Was Device Available for Evaluation? Yes
Device AgeMO
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/25/2022 Patient Sequence Number: 1
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